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The goal of this randomized clinical trial is to investigate whether modified enhanced recovery after surgery (ERAS) in oblique lumbar interbody fusion (OLIF) can shorten the postoperative hospital stay among patients with lumbar degenerative disease.
The main questions it aims to answer are:
Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.
Participants will be randomized into modified ERAS group, or control group.
The main questions it aims to answer are:
Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.
Participants will be randomized into modified ERAS group, or control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS group | Experimental | In this group, patients will be treated with modified ERAS protocol. |
|
| control group | Other | In this group, patients will be treated with routine protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified ERAS protocol | Other | Modified ERAS protocol for OLIF mainly include perioperative analgesic drug management, operation optimization in the anesthetic management, management of gastrointestinal function, and early mobilization management. Perioperative analgesic usage: Nonsteroidal anti-inflammatory drugs (NSAIDs) given when Visual Analogue Scale (VAS)>3. Prehabilitation: Respiratory function exercise; walk at least 200 meters daily. Gastrointestinal function management: Oral lactulose use routinely. Sedation and analgesia: patient status index (PSI) 25-50; analgesia nociception index (ANI) 50-70. Local anesthetic: local infiltration around the psoas muscle. Postop off-bed activity: start mobilization within 24h. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hospital stay | The length of hospital stay post-operation. | From the date of surgery to discharge, assessed up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative functional recovery | Evaluate the functional recovery through 6 Minutes Walk Distance. A longer walk distance indicates better functional recovery. | From the date of surgery to discharge, assessed up to 1 month |
| Postoperative pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Zhang, MD | Contact | 17610549095 | zhanglei@xwhosp.org | |
| Zhenlei Liu, MD | Contact | Zhenlei.liu@xwhosp.org |
| Name | Affiliation | Role |
|---|---|---|
| Hao Wu, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu hospital capital medical university | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D013130 | Spinal Stenosis |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| routine protocol | Other | Perioperative analgesic usage: NSAIDs given follow the patients requirement. Prehabilitation: None. Gastrointestinal function management: None. Sedation and analgesia: bispectral index (BIS) 40-60. Local anesthetic: None. Postop off-bed activity: mobilization follow the patients wish. |
|
Postoperative VAS at different time points for pain assessment. From 0-10, 0 indicates no pain, 10 indicates the most severe pain.
| From the date of surgery to 1 year post-operation |
| Postoperative lumbar neurological function assessment | Postoperative Japanese Orthopedics Association (JOA) at different time points for life quality assessment. From 0-29, A lower score indicates more dysfunction. | From the date of surgery to 1 year post-operation |
| Postoperative life quality assessment | Postoperative EuroQol-5 Dimensions (EQ-5D) at different time points for life quality assessment. | From the date of surgery to 1 year post-operation |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |